Regulatory Affairs Manager EU and US

Your new companyYou will be joining a leading CDMO organisation within the pharmaceutical sector, supporting the development and manufacture of complex drug products. The business is recognised for its innovative approach, strong client partnerships, and commitment to sustainability, working closely with global regulatory bodies. They are looking for an experienced regulatory professional to drive regulatory strategy across EU and US activities. Your new roleAs a Regulatory ManagerProvide strategic regulatory support to the assigned Regulatory Strategy Lead. Support EU and US development regulatory activities across ongoing programmes. EU Centralised Procedure SupportProvide strategic support for EMA centralised procedure activities.Assist with dossier compilation and submission coordination.Support life cycle management activities associated with development submissions.Ensure alignment of submission documentation with EU regulatory requirements and timelinesFDA Regulatory SupportSupport US regulatory activities and FDA-related documentation requirements.Assist with submission preparation and document management activities for US filings.Coordinate responses, updates, and submission components in collaboration with the Regulatory Strategy Lead.Your role will involve leading regulatory aspects of development projects, reviewing and approving key documentation (including DMFs, technical files, and CTD submissions), and acting as a primary point of contact for regulatory ..... full job details .....